BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MONITRON SYSTEM

    K Number: K874148 · Decision Jun 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    5
    Review Days
    246

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MONITRON SYSTEM
    K Number
    K874148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Health Products, Inc.
    Date Received
    October 13, 1987
    Decision Date
    June 15, 1988
    Product Code
    DRT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DRT), ordered by most recent decision date.

    The Circadia C300 System (C300)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    The Circadia C300 System (C300)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sleepiz One+ (Model 2.5)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sleepiz One+ (2.5)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    The Circadia C200 System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by American Health Products, Inc.

    K Number Device Name
    K974356 SURGEON'S GLOVES
    K923967 PATIENT EXAM GLOVES (POWDER FREE)
    K892291 PATIENT EXAM GLOVES (MFG. AMERICAN RUBBER PRODUCT)
    K892292 PATIENT EXAM GLOVES (MFG. MULTI-COM SDN BHD)